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Pharmacists' knowledge of drug food administration and their appropriate patient counseling a cross-sectional study from Palestine
Pharmacists have a responsibility in the treatment of patients. Interactions between food and drugs may lead to a loss of therapeutic effectiveness...
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Toxicity Spectrum of Anti-GD2 Immunotherapy: A Real-World Study Leveraging the US Food and Drug Administration Adverse Event Reporting System
BackgroundAnti-disialoganglioside (anti-GD2) monoclonal antibodies are effective immunotherapeutic drugs for treating neuroblastoma, yet their...
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Liver injury in children: signal analysis of suspected drugs based on the food and drug administration adverse event reporting system
BackgroundEvidence of drug-induced liver injury is abundant in adults but is lacking in children. Our aim was to identify suspected drug signals...
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Signal Detection and Assessment of Herb–Drug Interactions: Saudi Food and Drug Authority Experience
IntroductionNumerous investigations on herbal medicine that have been undertaken in the past several years demonstrate the general acceptance of its...
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Data mining and analysis of adverse event signals associated with teprotumumab using the Food and Drug Administration adverse event reporting system database
BackgroundTeprotumumab was approved by the US Food and Drug Administration (FDA) for the treatment of thyroid eye disease in 2020. However, its...
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Newer Antiseizure Medications and Suicidality: Analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) Database
BackgroundThe association between antiseizure medications (ASMs) and suicidality remains controversial. Analyses of additional datasets are needed to...
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Analysis of the association between Janus kinase inhibitors and malignant skin tumors using the Food and Drug Administration Adverse Event Reporting System
BackgroundMalignant skin tumors are adverse events of concern regarding Janus kinase (JAK) inhibitors.
AimThis study aimed to evaluate the...
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Evidence of Accidental Dosing Errors with Immediate-Release Sodium Oxybate: Data from the US Food and Drug Administration Adverse Event Reporting System
IntroductionSodium oxybate has been approved by the US Food and Drug Administration (FDA) to treat narcolepsy for 20 years; however, the only...
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Determining Commonalities in the Experiences of Patients with Rare Diseases: A Qualitative Analysis of US Food and Drug Administration Patient Engagement Sessions
BackgroundRare diseases are estimated to affect more than one in ten Americans. However, most patients with a rare disease face significant...
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Current Practices and Challenges When Submitting Patient Experience Data for Regulatory Decisions by the US Food and Drug Administration: An Industry Survey
ObjectivesTo understand industry practices and challenges when submitting patient experience data (PED) for regulatory decisions by the US Food and...
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Data mining for adverse drug reaction signals of daptomycin based on real-world data: a disproportionality analysis of the US Food and Drug Administration adverse event reporting system
BackgroundPrevious reports on daptomycin’s adverse drug reactions (ADRs) have been insufficient, often because of limited data. Pharmacovigilance...
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International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials
In June 2021, the US Food and Drug Administration (FDA) released a draft guidance for industry on core patient-reported outcomes (PROs) and related...
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Remdesivir for COVID-19 and acute kidney injury: disproportionality analysis of data from the U.S. Food and Drug Administration Adverse Event Reporting System
BackgroundEvidence about remdesivir-associated acute kidney injury (AKI) among patients with novel coronavirus disease 2019 (COVID-19) was...
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Amyotrophic Lateral Sclerosis as an Adverse Drug Reaction: A Disproportionality Analysis of the Food and Drug Administration Adverse Event Reporting System
IntroductionAmyotrophic lateral sclerosis is a fatal progressive disease with a still unclear multi-factorial etiology. This study focused on the...
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A pharmacovigilance study of the association between tetracyclines and hepatotoxicity based on Food and Drug Administration adverse event reporting system data
Background While tetracycline antibiotics are commonly prescribed in practice, the risk of drug-induced liver injury (DILI) remains controversial. Aim ...
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The Options for Neuraxial Drug Administration
Neuraxial drug administration, i.e., the injection of drugs into the epidural or intrathecal space to produce anesthesia or analgesia, is a technique...
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The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance During the COVID-19 Pandemic
IntroductionOn 4 February, 2020, the Secretary of the Department of Health and Human Services declared a public health emergency related to...
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Postmarketing safety of orphan drugs: a longitudinal analysis of the US Food and Drug Administration database between 1999 and 2018
BackgroundInformation about the specific regulatory environment of orphan drugs is scarce and inconsistent. Uncertainties surrounding the...
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US Food and Drug Administration regulatory updates in neuro-oncology
ObjectiveContemporary management of patients with neuro-oncologic disease requires an understanding of approvals by the US Food and Drug...
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Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System
IntroductionDeliberate self-poisoning (DSP) using drugs is the preferred method of suicide at a global level. Its investigation is hampered by...
